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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plate, cranioplasty, preformed, non-alterable
Product CodeGXN
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
FIN-CERAMICA FAENZA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA SPA
  SUBSTANTIALLY EQUIVALENT 1
KONTOUR(XI’AN) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LONGEVITI NEURO SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 6
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 63 63
2021 63 63
2022 57 57
2023 32 32
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 138 138
Defective Device 56 56
Insufficient Information 12 12
Break 11 11
Appropriate Term/Code Not Available 7 7
Defective Component 6 6
Inadequacy of Device Shape and/or Size 3 3
Migration 3 3
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Incomplete or Missing Packaging 1 1
Crack 1 1
Material Erosion 1 1
Material Integrity Problem 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Decoupling 1 1
Product Quality Problem 1 1
Missing Information 1 1
Melted 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 101 101
No Clinical Signs, Symptoms or Conditions 55 55
No Code Available 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Insufficient Information 16 16
Post Operative Wound Infection 14 14
Injury 10 10
Failure of Implant 9 9
No Known Impact Or Consequence To Patient 6 6
Cerebrospinal Fluid Leakage 5 5
Unspecified Tissue Injury 4 4
No Consequences Or Impact To Patient 3 3
Non-union Bone Fracture 3 3
Pain 3 3
Hematoma 3 3
Wound Dehiscence 3 3
Impaired Healing 3 3
No Information 2 2
No Patient Involvement 2 2
Swelling/ Edema 2 2
Bacterial Infection 2 2
Pocket Erosion 2 2
Tissue Breakdown 2 2
Cognitive Changes 1 1
Metal Related Pathology 1 1
Seizures 1 1
Hemorrhage, Extradural 1 1
Intracranial Hemorrhage 1 1
Paralysis 1 1
Dry Mouth 1 1
Nerve Damage 1 1
Numbness 1 1
Visual Impairment 1 1
Hair Loss 1 1
Drug Resistant Bacterial Infection 1 1
Fall 1 1
Abscess 1 1
Hydrocephalus 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Infection 1 1
Blurred Vision 1 1
Hemorrhage/Bleeding 1 1
Eye Pain 1 1

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